An interventional study of Single-Port Robot-Assisted Radical Distal Gastrectomy and Multi-Port Robot-Assisted Radical Distal Gastrectomy in STOMACH NEOPLASM and Robotic Surgical Procedures, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment
This multicenter randomized non-inferiority trial evaluates single-port versus multi-port robotic-assisted radical distal gastrectomy in patients with gastric cancer. A prespecified prospective substudy will assess early postoperative pain, abdominal wall trauma, and early recovery between the two surgical approaches.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 212 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 83 studies on the registry; 57 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this group will undergo single-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
Procedure: Single-Port Robot-Assisted Radical Distal Gastrectomy
Participants randomized to this group will undergo conventional multi-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
Procedure: Multi-Port Robot-Assisted Radical Distal Gastrectomy
Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a single-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a multi-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach
Technical success is defined as completion of the protocol-specified gastrectomy, lymph node dissection, and gastrointestinal reconstruction using the robotic surgical approach assigned at randomization. In the single-port group, technical success requires completion using the single-port robotic system without conversion to multi-port robotic surgery, conventional laparoscopic surgery, or open surgery, and without any unplanned additional port beyond those permitted by the protocol. In the multi-port group, technical success requires completion using the multi-port robotic system without conversion to conventional laparoscopic surgery or open surgery. Failure to complete the assigned robotic procedure because of participant-related, operative, or device-related reasons will be classified as technical failure. The prespecified noninferiority margin is -10 percentage points.
Time frame: At the end of surgery
Total Operative Time
Total duration of the surgical procedure, recorded in minutes according to the protocol-defined timing criteria.
Time frame: Intraoperative
Robotic Docking Time
Duration required for robotic docking, recorded in minutes according to the protocol-defined timing criteria.
Time frame: Intraoperative
Robotic Console Time
Duration of robotic console operation, recorded in minutes according to the protocol-defined timing criteria.
Time frame: Intraoperative
Intraoperative Blood Loss
Estimated volume of blood loss during surgery, recorded in milliliters.
Time frame: Intraoperative
Percentage of Participants With Intraoperative Complications
Intraoperative complications will be recorded and graded according to the Satava classification system.
Time frame: Intraoperative
Percentage of Participants With R0 Resection
R0 resection is defined as complete tumor resection with no microscopic residual tumor at the resection margins, as determined by postoperative pathological examination.
Time frame: At completion of postoperative pathological assessment, within 30 days after surgery
Number of Lymph Nodes Retrieved
Total number of lymph nodes retrieved and identified during postoperative pathological examination.
Time frame: At completion of postoperative pathological assessment, within 30 days after surgery
Number of Metastatic Lymph Nodes
Total number of pathologically confirmed metastatic lymph nodes identified during postoperative pathological examination.
Time frame: At completion of postoperative pathological assessment, within 30 days after surgery
Overall postoperative complications
Any postoperative complication occurring from the end of surgery through postoperative Day 30 will be recorded according to the predefined study protocol and graded using the Clavien-Dindo classification.
Time frame: From the end of surgery through 30 days after surgery
Percentage of Participants With Clavien-Dindo Grade III or Higher Postoperative Complications
Severe postoperative complications are defined as postoperative complications classified as Clavien-Dindo Grade III or higher.
Time frame: From the end of surgery through 30 days after surgery
Specific surgery-related complications
Prespecified surgery-related complications include anastomotic leakage, anastomotic bleeding or stenosis, duodenal stump leakage, pancreatic fistula or postoperative pancreatitis, intra-abdominal bleeding, intra-abdominal infection or abscess, bile leakage, chylous or lymphatic leakage, delayed gastric emptying, postoperative ileus or bowel obstruction, internal hernia, bowel perforation or ischemic necrosis, and wound complications requiring clinical intervention.
Time frame: From the end of surgery through 30 days after surgery
Percentage of Participants With Unplanned Reoperation Within 30 Days After Surgery
Percentage of participants requiring an unplanned surgical reoperation for any postoperative reason within 30 days after the index surgery.
Time frame: Within 30 days after surgery
Percentage of Participants With Unplanned Readmission Within 30 Days After Surgery
Percentage of participants requiring an unplanned hospital readmission within 30 days after the index surgery.
Time frame: Within 30 days after surgery
Percentage of Participants Who Die Within 30 Days After Surgery
All-cause mortality occurring within 30 days after the index surgery.
Time frame: Within 30 days after surgery
Pain and Early Recovery Substudy: Estimated Marginal Mean Resting VAS Pain Score Across Postoperative Days 1-3
This is the prespecified primary outcome of the embedded postoperative pain and early recovery substudy, which is planned to include 140 participants from the parent randomized trial. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Days 1, 2, and 3 according to a standardized assessment procedure. For the primary analysis, a linear mixed-effects model for repeated measures will be applied, adjusting for pre-specified confounding factors including study site. It will estimate the overall mean resting VAS score across postoperative Days 1-3 for each group, together with the between-group difference and its 95% confidence interval. Higher VAS scores indicate greater pain intensity. The prespecified superiority hypothesis evaluates whether the overall resting VAS pain level across postoperative Days 1-3 is lower in the single-port group than in the multi-port group.
Time frame: Postoperative Days 1 through 3
Pain and Early Recovery Substudy: Resting VAS Pain Score at 6 Hours After Surgery
This is a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6 hours after surgery according to the standardized assessment procedure. Higher VAS scores indicate greater pain intensity.
Time frame: 6 hours after surgery
Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 1
This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 1 according to the standardized assessment procedure. VAS scores on postoperative Day 1 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 1 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.
Time frame: Postoperative Day 1
Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 2
This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 2 according to the standardized assessment procedure. VAS scores on postoperative Day 2 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 2 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.
Time frame: Postoperative Day 2
Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 3
This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 3 according to the standardized assessment procedure. VAS scores on postoperative Day 3 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 3 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.
Time frame: Postoperative Day 3
Pain and Early Recovery Substudy: Percentage of Participants Requiring Rescue Analgesia
This is a prespecified secondary or supportive outcome of the embedded postoperative pain and early recovery substudy. Rescue analgesia is defined as additional analgesic treatment administered because of inadequate pain control beyond the protocol-specified routine postoperative analgesic regimen. The proportion of participants requiring at least one rescue analgesic intervention during the prespecified postoperative observation period will be recorded and compared between the single-port and multi-port groups. This outcome does not have a separate confirmatory superiority hypothesis.
Time frame: From the end of surgery through postoperative Day 3
Pain and Early Recovery Substudy: Cumulative Postoperative Opioid Consumption in Morphine Milligram Equivalents
This is a prespecified secondary or supportive outcome of the embedded postoperative pain and early recovery substudy. All postoperative opioid analgesics administered during the prespecified observation period will be recorded. Individual opioid doses will be converted to morphine milligram equivalents (MME) using a prespecified standardized conversion method, and cumulative MME will be calculated for each participant to allow quantitative comparison of postoperative opioid requirements between the single-port and multi-port groups. This outcome does not have a separate confirmatory superiority hypothesis.
Time frame: From the end of surgery through postoperative Day 3
Total Abdominal Wall Incision Length
Total abdominal wall incision length will be calculated as the sum of the lengths of all abdominal surgical incisions and recorded in centimeters according to the standardized study assessment procedure. This outcome will be assessed in randomized participants to compare abdominal wall trauma between the single-port and multi-port robotic surgical groups. It is also included as a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy.
Time frame: At the end of surgery
Maximum Length of a Single Abdominal Wall Incision
The length of the longest individual abdominal wall surgical incision will be measured in centimeters according to the standardized study assessment procedure. This outcome will be assessed in randomized participants to compare the extent of abdominal wall trauma between the single-port and multi-port robotic surgical groups. It is also included as a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy.
Time frame: At the end of surgery
Time to First Postoperative Flatus
Time to first postoperative flatus is defined as the time from the end of surgery to the first passage of flatus and will be recorded in hours. This outcome will be assessed in randomized participants to compare early postoperative gastrointestinal recovery between the single-port and multi-port robotic surgical groups.
Time frame: Up to 30 days after surgery
Time to First Postoperative Defecation
Time to first postoperative defecation is defined as the time from the end of surgery to the first postoperative bowel movement and will be recorded in hours. This outcome will be assessed in randomized participants to compare early postoperative gastrointestinal recovery between the single-port and multi-port robotic surgical groups.
Time frame: Up to 30 days after surgery
Time to First Postoperative Ambulation
Time to first postoperative walking lasting more than 5 minutes is defined as the time from the end of surgery to the first postoperative walking episode lasting more than 5 minutes and will be recorded in hours. Brief standing or walking episodes lasting 5 minutes or less will not be considered as meeting this outcome. This outcome will be assessed in randomized participants to compare early postoperative functional recovery between the single-port and multi-port robotic surgical groups. It is also included as a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy.
Time frame: Up to 30 days after surgery
Time to First Postoperative Oral Intake
Time to first postoperative oral intake is defined as the time from the end of surgery to the first postoperative oral intake of liquid, soft food, or regular food and will be recorded in days. This outcome will be assessed in randomized participants to compare early postoperative recovery between the single-port and multi-port robotic surgical groups.
Time frame: Up to 30 days after surgery
Time to Meeting Discharge Criteria
Time to meeting discharge criteria is defined as the time from the end of surgery until the participant meets all prespecified discharge criteria. These criteria include stable vital signs without fever; recovery of gastrointestinal function with adequate oral intake and no requirement for intravenous nutritional support; ability to ambulate independently without significant discomfort; and satisfactory wound and drainage status with laboratory findings considered clinically acceptable according to the study protocol. This outcome will be assessed in randomized participants to compare early postoperative recovery between the single-port and multi-port robotic surgical groups.
Time frame: Up to 30 days after surgery
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First Affiliated Hospital of Wenzhou Medical University