Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty

NCT07820696 | Recruiting

• 1 other identifier: 2026/05-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Diseases; Mechanical Bowel Preparation

Keywords

Colorectal Surgery; Mechanical Bowel Preparation; Oral Laxative; Randomized Controlled Trial; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum

Secondary Outcomes (15)

• Operative Difficulty Score

  At the end of surgery, on the day of the procedure

• Estimated Intraoperative Blood Loss

  Intraoperatively, on the day of surgery

• Incidence of Intraoperative Serosal Injury

  Intraoperatively, on the day of surgery

• Incidence of Intraoperative Organ Injury

  Intraoperatively, on the day of surgery

• Incidence of Intraoperative Bleeding Requiring Intervention

  Intraoperatively, on the day of surgery

Study Arms (2)

Oral Laxative Plus Rectal Enema

EXPERIMENTAL

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

Rectal Enema Alone

ACTIVE COMPARATOR

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

Interventions

Oral Laxative DRUG

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.

Oral Laxative Plus Rectal Enema

Rectal Enema DRUG

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.

Oral Laxative Plus Rectal Enema; Rectal Enema Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective laparoscopic colorectal resection
• American Society of Anesthesiologists (ASA) physical status I-III
• Able and willing to provide written informed consent

You may not qualify if:

• Requirement for emergency surgery
• Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
• Anticipated extensive intra-abdominal adhesions
• Active inflammatory bowel disease
• Pregnancy
• Serious systemic disease constituting a contraindication to oral laxative use
• Inability to perform standardized intraoperative small-bowel diameter measurements

Sponsors & Collaborators

• Van Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Türkiye, Van Training and Research Hospital

Van, Van, 65300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Laxatives

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

İbrahim Doğan

CONTACT

+905313884966; dogan_203@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operating surgeon assessing intraoperative small-bowel diameter and operative difficulty will be blinded to the participant's assigned bowel preparation group. Bowel preparation will be administered by clinical staff who are not involved in intraoperative outcome assessment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomly assigned to one of two parallel groups receiving either oral laxative plus rectal enema preparation or rectal enema preparation alone before elective laparoscopic colorectal surgery. Each participant will remain in the assigned group throughout the study.

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 15, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)