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

NCT07702799 | Recruiting DMC

• 1 other identifier: ENDO-DIET-RCT-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; Laparoscopic Surgery; Bowel Preparation; Low-Residue Diet; Rectal Enema; Surgical Exposure; Trendelenburg Position; Pneumoperitoneum; Gynecologic Oncology

Outcome Measures

Primary Outcomes (3)

• Intraoperative Visual Index Score

  Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.

  Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar

• Minimum Trendelenburg Position Required for Adequate Surgical Exposure

  The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.

  Intraoperatively

• Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure

  The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.

  Intraoperatively

Secondary Outcomes (4)

• Operative Time

  During surgery

• Length of Hospital Stay

  At hospital discharge, assessed up to 30 days after surgery

• Time to First Flatus

  From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days

• Patient Tolerance of Bowel Preparation

  From preoperative bowel preparation until postoperative day 1

Study Arms (2)

Low-Residue Diet

EXPERIMENTAL

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

Behavioral: Low-Residue Diet

Rectal Enema

ACTIVE COMPARATOR

Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol

Drug: Sodium Phosphate Rectal Enema

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.

Low-Residue Diet

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.

Rectal Enema

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 to 90 years.
• Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
• Willing and able to provide written informed consent.

You may not qualify if:

• Planned open (abdominal) surgery.
• Known allergy or contraindication to sodium phosphate rectal enema.
• Age over 90 years.
• Refusal or inability to provide written informed consent.

Sponsors & Collaborators

• Mahmut Yassa: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Mahmut Yassa, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmut Yassa, MD

CONTACT

+90 539 663 54 84; mahmut_yassa@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the interventions, participants and the study nurse responsible for preoperative bowel preparation cannot be blinded. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment. Postoperative data collection and statistical analyses will be performed by the study investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecologic Oncology Specialist

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either a low-residue diet or a rectal enema before surgery. Group allocation will be performed using a computer-generated randomization list with sequentially numbered opaque envelopes. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary study results and ending 3 years after publication.
• Access Criteria: Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.

Locations

TU (1)