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NCT Number: NCT05352074

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Slow Transit Constipation Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Army Medical Center (Daping Hospital), Yuzhong, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients (≥18 years of age) of either sex
  • Patients with conditions in agreement with the Roman IV criteria of functional constipation
  • Patients have less than one complete spontaneous bowel movement per week
  • Patients rely on laxatives to assist defecation for a long time
  • More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
  • Patients were refractory to conservative treatment for more than 1 year
  • Patients with a strong desire for surgery

Exclusion criteria

  • Pregnant or breast-feeding women
  • Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
  • Patients with colorectal neoplasms
  • Patients with small intestinal slow transit
  • Patients with constipation-predominant irritable bowel syndrome
  • Patients with inflammatory bowel disease
  • Patients with ileostomy
  • Patients with severe psychiatric disease

Treatment and study plan

Total colectomy with ileorectal anastomosis

Procedure

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.

Subtotal colectomy with cecal-rectal anastomosis

Procedure

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.

Primary outcomes

  1. Wexner Constipation Score

    Time frame: From the pre-operation to 36 months following surgery

    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)

Secondary outcomes

  1. Gastrointestinal Quality of Life Index

    Time frame: From the pre-operation to 36 months following surgery

    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).

  2. 36-item short-form health survey

    Time frame: From the pre-operation to 36 months following surgery

    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).

  3. The incidence of complications

    Time frame: From the pre-operation to 36 months following surgery

    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.

  4. The number of bowel movements per week

    Time frame: From the pre-operation to 36 months following surgery

    The number of bowel movements will be recorded in terms of times per week.

  5. Wexner's incontinence score

    Time frame: From the pre-operation to 36 months following surgery

    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).

  6. The incidence of abdominal pain

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.

  7. The incidence of bloating

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of bloating will be recorded in terms of percent

  8. The incidence of diarrhea

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of diarrhea will be recorded in terms of percent.

  9. The incidence of straining

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of straining will be recorded in terms of percent.

  10. The incidence of laxative use

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of laxative use will be recorded in terms of percent.

  11. The incidence of enema use

    Time frame: From the pre-operation to 36 months following surgery

    The incidence of enema use use will be recorded in terms of percent.

  12. Intraoperative measures

    Time frame: Perioperative period

    Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Apr 28, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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