An interventional study of Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery in Colorectal Cancer, Colonic Neoplasms and Rectal Neoplasms, sponsored by Ruijin Hospital. Withdrawn at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）.
Procedure: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Procedure: Single-incision Laparoscopic Surgery
Patients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
Also known as: SILSC
Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Also known as: CLSC
Postoperative complications
Postoperative complications rate 30 days after surgery
Time frame: 30 days after surgery
Operative time
Operative time（minutes）
Time frame: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Time frame: intraoperative
Incision length
Incision length（centimeters，cm）
Time frame: intraoperative
Lymph node detection
Lymph nodes harvested（numbers）
Time frame: 14 days after surgery
Incisal margin
Length of proximal and distal margin （centimeters，cm）
Time frame: 14 days after surgery
Tumor size
The diameter of tumors（centimeters，cm）
Time frame: 14 days after surgery
Length of stay
Duration of hospital stay（days after surgery）
Time frame: 1-14 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Time frame: 1-14 days after surgery
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Time frame: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Time frame: 60 months after surgery
Plan to share: Undecided
Start is estimated for Aug 2020; primary completion for Dec 2020, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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