Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVan Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Requirement for emergency surgery
Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
Anticipated extensive intra-abdominal adhesions
Active inflammatory bowel disease
Trial design
Design model
Parallel
Treatments tested in this trial
Oral Laxative
DrugParticipants 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
DrugParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Oral Laxative Plus Rectal EnemaExperimental treatment 2 interventions
Group B: Rectal Enema AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 pneumoperitoneum2
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 pneumoperitoneumSecondary outcomes
1
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 procedure2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov