Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative Jejunal Diameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral Laxative Plus Rectal Enema
Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery.
干预措施: Oral Laxative (Drug)
Oral Laxative Plus Rectal Enema
Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery.
干预措施: Rectal Enema (Drug)
Rectal Enema Alone
Participants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery.
干预措施: Rectal Enema (Drug)
结局指标
主要结局
Intraoperative Jejunal Diameter
时间窗: 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
时间窗: 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.
次要结局
- Operative Difficulty Score(At the end of surgery, on the day of the procedure)
- Estimated Intraoperative Blood Loss(Intraoperatively, on the day of surgery)
- Incidence of Intraoperative Serosal Injury(Intraoperatively, on the day of surgery)
- Incidence of Intraoperative Organ Injury(Intraoperatively, on the day of surgery)
- Incidence of Intraoperative Bleeding Requiring Intervention(Intraoperatively, on the day of surgery)
- Requirement for an Additional Laparoscopic Port(Intraoperatively, on the day of surgery)
- Conversion From Laparoscopic to Open Surgery(Intraoperatively, on the day of surgery)
- Incidence of Any Postoperative Complication Within 30 Days(From the day of surgery through postoperative day 30)
- Incidence of Anastomotic Leakage Within 30 Days(From the day of surgery through postoperative day 30)
- Incidence of Surgical Site Infection Within 30 Days(From the day of surgery through postoperative day 30)
- Incidence of Postoperative Ileus Within 30 Days(From the day of surgery through postoperative day 30)
- Time Required for Bowel Manipulation and Displacement(Intraoperatively, on the day of surgery)
- Time Required for Intraoperative Bowel Diameter Measurements(Intraoperatively, on the day of surgery)
- Time Required to Complete the Anastomosis(Intraoperatively, on the day of surgery)
- Total Operation Time(Intraoperatively, on the day of surgery)
研究者
IBRAHIM DOGAN
MD
Van Training and Research Hospital