Colorectal Diseases, Mechanical Bowel Preparation
Conditions
Keywords
Colorectal Surgery, Mechanical Bowel Preparation, Oral Laxative, Randomized Controlled Trial, Laparoscopic Surgery
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.
Detailed description
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.
Interventions
DRUGOral Laxative
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.
DRUGRectal Enema
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.
Sponsors
Van Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Jejunal Diameter | 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. |
| Intraoperative Ileal Diameter | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative Difficulty Score | 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. |
| Estimated Intraoperative Blood Loss | Intraoperatively, on the day of surgery | The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records. |
| Incidence of Intraoperative Serosal Injury | Intraoperatively, on the day of surgery | The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record. |
| Incidence of Intraoperative Organ Injury | 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. |
| Incidence of Intraoperative Bleeding Requiring Intervention | Intraoperatively, on the day of surgery | The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis. |
| Requirement for an Additional Laparoscopic Port | 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. |
| Conversion From Laparoscopic to Open Surgery | Intraoperatively, on the day of surgery | The number of participants whose planned laparoscopic procedure is converted to an open surgical approach. |
| Incidence of Any Postoperative Complication Within 30 Days | 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. |
| Incidence of Anastomotic Leakage Within 30 Days | 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. |
| Incidence of Surgical Site Infection Within 30 Days | 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. |
| Incidence of Postoperative Ileus Within 30 Days | 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. |
| Time Required for Bowel Manipulation and Displacement | Intraoperatively, on the day of surgery | The time required to manipulate the bowel and displace it from the operative field during surgery. |
| Time Required for Intraoperative Bowel Diameter Measurements | Intraoperatively, on the day of surgery | The time required to perform intraoperative measurements of the jejunal and ileal diameters. |
| Time Required to Complete the Anastomosis | Intraoperatively, on the day of surgery | The time from initiation of anastomosis construction to completion of the anastomosis during surgery. |
| Total Operation Time | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİbrahim Doğan
Outcome results
None listed