Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis

NCT06036862

Anastomotic Stenosis

RECRUITING NA

Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer

NCT03097276

Colon and/or Rectal Resection With Anastomosis for Cancer

COMPLETED NA

PE-Bacon for Late Complications of Chronic Radiation-induced Rectal Injury

NCT05607927

Chronic Radiation Injury

NOT_YET_RECRUITING PHASE3

Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy

NCT02308631

Colonic Neoplasms Rectal Neoplasms Fecal Incontinence

COMPLETED PHASE1

Impact of Iron Infusion in Anemic Patients on Their Postoperative Outcome After Colorectal Surgery

NCT05522790

Anemia, Iron Deficiency Colorectal Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic radiation proctitis (CRP) is a common complication after radiotherapy of pelvic malignancies, accounting for 5%-20% of cases. Rectal bleeding is the most common symptom, which accounts for \> 80% of CRP patients. Mild to moderate bleeding can be controlled by medical agents like sucralfate, endoscopic argon plasma coagulation (APC) or topical formalin. Severe and refractory bleeding is still problematic and refractory to these above medical treatments. Our previous retrospective study found that colostomy obtained a higher rate of bleeding remission (94% vs 12%) in 6 months, especially in control of transfusion-dependent bleeding (100% vs0%), when compared to conservative treatments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Radiation Proctitis Rectal Bleeding Colostomy Stoma Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transverse colostomy

Diverting transverse colostomy were conducted under general or epidural anesthesia in the operating room. The transverse colon was pulled out through one 2\*2cm incision. The omentum was dissected from transverse colon, and a double-cavity stoma of transverse colon was then created.

Group Type EXPERIMENTAL

Transverse colostomy

Intervention Type PROCEDURE

Transverse double-cavity colostomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transverse colostomy

Transverse double-cavity colostomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically diagnosed with pelvic malignancies, including gynecologic, prostate, or urinary cancers;
* History of pelvic radiation;
* No tumor recurrence or metastasis;
* Refractory hemorrhagic CRP;
* Time of rectal bleeding \>6 months;
* SOBS=3 points;
* severe anemia （Hb≤7 g/dl）or transfusion history for CRP bleedings.

Exclusion Criteria

* Severe complications of CRP, including deep ulcer or fistula, stricture, necrosis, refractory perianal pain;
* Other hemorrhagic diseases, like III-IV degree hemorrhoids;
* History of colon or rectum resection;
* Intestinal obstruction and surgery needed;
* with contraindications to general anaesthesia (ASA class 4 or 5);
* pregnant or breast-feeding;
* history of mental disorder.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No