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NCT Number: NCT07820696

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

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.

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Key information

Conditions

Colorectal Diseases Mechanical Bowel Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Türkiye, Van Training and Research Hospital

Van, 65300, Turkey (Türkiye)

Location status: Recruiting

Location contact

İbrahim Doğan

CONTACT

[email protected]

+905313884966

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Intraoperative Jejunal Diameter

    Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum

    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.

  2. Intraoperative Ileal Diameter

    Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum

    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.

Secondary outcomes

  1. Operative Difficulty Score

    Time frame: At the end of surgery, on the day of the procedure

    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.

  2. Estimated Intraoperative Blood Loss

    Time frame: Intraoperatively, on the day of surgery

    The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.

  3. Incidence of Intraoperative Serosal Injury

    Time frame: Intraoperatively, on the day of surgery

    The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.

  4. Incidence of Intraoperative Organ Injury

    Time frame: Intraoperatively, on the day of surgery

    The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.

  5. Incidence of Intraoperative Bleeding Requiring Intervention

    Time frame: Intraoperatively, on the day of surgery

    The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.

  6. Requirement for an Additional Laparoscopic Port

    Time frame: Intraoperatively, on the day of surgery

    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.

  7. Conversion From Laparoscopic to Open Surgery

    Time frame: Intraoperatively, on the day of surgery

    The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.

  8. Incidence of Any Postoperative Complication Within 30 Days

    Time frame: From the day of surgery through postoperative day 30

    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.

  9. Incidence of Anastomotic Leakage Within 30 Days

    Time frame: From the day of surgery through postoperative day 30

    The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.

  10. Incidence of Surgical Site Infection Within 30 Days

    Time frame: From the day of surgery through postoperative day 30

    The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.

  11. Incidence of Postoperative Ileus Within 30 Days

    Time frame: From the day of surgery through postoperative day 30

    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.

  12. Time Required for Bowel Manipulation and Displacement

    Time frame: Intraoperatively, on the day of surgery

    The time required to manipulate the bowel and displace it from the operative field during surgery.

  13. Time Required for Intraoperative Bowel Diameter Measurements

    Time frame: Intraoperatively, on the day of surgery

    The time required to perform intraoperative measurements of the jejunal and ileal diameters.

  14. Time Required to Complete the Anastomosis

    Time frame: Intraoperatively, on the day of surgery

    The time from initiation of anastomosis construction to completion of the anastomosis during surgery.

  15. Total Operation Time

    Time frame: Intraoperatively, on the day of surgery

    The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.

Study contacts

Contact information is provided by the study sponsor or research team.

İbrahim Doğan

CONTACT

[email protected]

+905313884966

Sponsors and collaborators

Lead sponsor

Van Training and Research Hospital

Other Gov

Registry information

Acronym: OLAX-CRC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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