An interventional study of Oral Laxative and Rectal Enema in Colorectal Diseases and Mechanical Bowel Preparation, sponsored by Van Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Van Training and Research Hospital · Not applicable, Interventional, and Other
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty. Adult patients scheduled for elective laparoscopic colorectal resection will be randomly assigned to receive either oral laxative plus rectal enema preparation or rectal enema preparation alone. During surgery, the diameters of the jejunum and ileum will be measured using a standardized method. The study will also compare operative difficulty, bowel manipulation time, operation duration, need for additional ports, conversion to open surgery, intraoperative complications, blood loss, and early postoperative outcomes between the two groups. The findings may help clarify whether oral laxative use influences intraoperative conditions during laparoscopic colorectal surgery.
Mechanical bowel preparation is commonly used before elective colorectal surgery. Although its effects on postoperative outcomes have been widely investigated, limited evidence is available regarding the effect of oral laxatives on intraoperative small-bowel distension and technical difficulty during laparoscopic colorectal surgery. Increased intraluminal fluid following oral laxative administration may lead to small-bowel distension, potentially impairing surgical exposure and increasing the need for bowel manipulation.
In this study, small-bowel diameter will be assessed intraoperatively using a standardized measurement method after laparoscopic access and establishment of pneumoperitoneum. Jejunal diameter will be measured approximately 50 cm distal to the ligament of Treitz, and ileal diameter approximately 20 cm proximal to the ileocecal valve. Measurements will be performed in the transverse plane without applying mesenteric tension and, when feasible, the mean of two measurements will be recorded. At the end of the operation, the operating surgeon will assess overall operative difficulty using a Likert-type scale ranging from very easy to very difficult. This pilot study is intended to provide preliminary evidence for the design of future adequately powered studies and to support the evaluation of current bowel-preparation practices.
Van Training and Research Hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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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 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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery.
Drug: Oral Laxative · Drug: Rectal Enema
Participants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery.
Drug: Rectal Enema
Participants assigned to the experimental arm will receive an oral laxative as part of preoperative mechanical bowel preparation, in addition to a rectal enema, before elective laparoscopic colorectal surgery. The oral laxative will be administered according to the institution's standard preoperative bowel preparation protocol.
Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery. Participants in the comparator arm will receive the rectal enema without an oral laxative.
Intraoperative Jejunal Diameter
Jejunal diameter will be measured in centimeters approximately 50 cm distal to the ligament of Treitz, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Intraoperative Ileal Diameter
Ileal diameter will be measured in centimeters approximately 20 cm proximal to the ileocecal valve, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Operative Difficulty Score
Overall operative difficulty will be assessed by the operating surgeon at the end of the procedure using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, and 5 = very difficult. Higher scores indicate greater operative difficulty.
Time frame: At the end of surgery, on the day of the procedure
Estimated Intraoperative Blood Loss
The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Serosal Injury
The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Organ Injury
The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Bleeding Requiring Intervention
The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.
Time frame: Intraoperatively, on the day of surgery
Requirement for an Additional Laparoscopic Port
The number of participants in whom placement of at least one additional laparoscopic port beyond the planned port configuration is required to complete the procedure.
Time frame: Intraoperatively, on the day of surgery
Conversion From Laparoscopic to Open Surgery
The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.
Time frame: Intraoperatively, on the day of surgery
Incidence of Any Postoperative Complication Within 30 Days
The number of participants who experience at least one surgery-related postoperative complication within 30 days after surgery. Each participant will be counted once, regardless of the number of complications experienced.
Time frame: From the day of surgery through postoperative day 30
Incidence of Anastomotic Leakage Within 30 Days
The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.
Time frame: From the day of surgery through postoperative day 30
Incidence of Surgical Site Infection Within 30 Days
The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.
Time frame: From the day of surgery through postoperative day 30
Incidence of Postoperative Ileus Within 30 Days
The number of participants who develop postoperative ileus within 30 days after surgery, as documented in the medical record based on delayed recovery or interruption of gastrointestinal function.
Time frame: From the day of surgery through postoperative day 30
Time Required for Bowel Manipulation and Displacement
The time required to manipulate the bowel and displace it from the operative field during surgery.
Time frame: Intraoperatively, on the day of surgery
Time Required for Intraoperative Bowel Diameter Measurements
The time required to perform intraoperative measurements of the jejunal and ileal diameters.
Time frame: Intraoperatively, on the day of surgery
Time Required to Complete the Anastomosis
The time from initiation of anastomosis construction to completion of the anastomosis during surgery.
Time frame: Intraoperatively, on the day of surgery
Total Operation Time
The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.
Time frame: Intraoperatively, on the day of surgery
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
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