Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer

Sponsor
Mahmut Yassa
Study ID
NCT07702799
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Residue Diet — BEHAVIORAL
    Participants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period.
  • Sodium Phosphate Rectal Enema — DRUG
    Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol.

Study Details

The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery. The main questions it aims to answer are: * Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema? * Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view? * Does either bowel preparation method cause more discomfort or side effects before surgery? Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery. Participants will: * Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery. * Undergo standard laparoscopic surgery for endometrial cancer. * Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Jan 15, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Residue Diet
    Participants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery
  • Active Comparator: Rectal Enema
    Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol

Primary Outcome Measure

Intraoperative Visual Index Score [ Time Frame: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar ]

Central Contacts

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