Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.
Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.
Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China
RECRUITINGWexner Constipation Score
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
Time frame: From the pre-operation to 36 months following surgery
Gastrointestinal Quality of Life Index
Gastrointestinal Quality of Life Index will be recorded in terms of scores. There are The four possible answers to every question, scored from 0 points (worst) to 4 points (best). The final sum ranges from 0(worst) to 144(best).
Time frame: From the pre-operation to 36 months following surgery
36-item short-form health survey
There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores. Once the questionnaire was applied to the patients, a summary calculation and a linear transformation were performed to obtain a score within a scale from 0(worst) to 100(best).
Time frame: From the pre-operation to 36 months following surgery
The incidence of complications
Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.
Time frame: From the pre-operation to 36 months following surgery
The number of bowel movements per week
The number of bowel movements will be recorded in terms of times per week.
Time frame: From the pre-operation to 36 months following surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
Lanzhou, Gansu, China
RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
WITHDRAWNThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
WITHDRAWNRenmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGGeneral Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shengyang, Liaoning, China
RECRUITINGQingdao Municipal Hospital
Qingdao, Shandong, China
RECRUITINGRenji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China
RECRUITING...and 6 more locations
Wexner's incontinence score
The Wexner's incontinence score will be recorded in terms of scores. the sacles have 5 items to quantify incontinence grade and frequency and its effect on ordinary life. Each question is answered on a scale of 0 to 4, the global score ranging from 0 (best) to 20 (worst).
Time frame: From the pre-operation to 36 months following surgery
The incidence of abdominal pain
The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.
Time frame: From the pre-operation to 36 months following surgery
The incidence of bloating
The incidence of bloating will be recorded in terms of percent
Time frame: From the pre-operation to 36 months following surgery
The incidence of diarrhea
The incidence of diarrhea will be recorded in terms of percent.
Time frame: From the pre-operation to 36 months following surgery
The incidence of straining
The incidence of straining will be recorded in terms of percent.
Time frame: From the pre-operation to 36 months following surgery
The incidence of laxative use
The incidence of laxative use will be recorded in terms of percent.
Time frame: From the pre-operation to 36 months following surgery
The incidence of enema use
The incidence of enema use use will be recorded in terms of percent.
Time frame: From the pre-operation to 36 months following surgery
Intraoperative measures
Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.
Time frame: Perioperative period