Clinical trial NCT03397901: Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
Official title: Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Radiation Proctitis
Rectal Bleeding
Colostomy Stoma
Anemia
Keywords: chronic radiation proctitis
rectal bleeding
transverse colostomy
refractory
moderate to severe anemia
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: remission rate of rectal bleeding after colostomy
timeFrame: 6 mon after colostomy
Secondary outcomes:
measure: Remission rate of rectal bleeding
timeFrame: 1 year, 2years, 3 years
measure: Rate of colostomy closure
timeFrame: 1 years, 1.5 years, 2 years
measure: Rate of severe CRP complications
timeFrame: 3 years
measure: endoscopic score
timeFrame: 1 year
measure: endoscopic score
timeFrame: baseline, 6 months, 1 year, 2 years, 3 years
measure: Quality of life by EORTC scores
timeFrame: baseline, 6 months, 1 year, 2 years, 3 years
measure: Anorectal function outcomes
timeFrame: baseline, 6 months, 1 year, 2 years, 3 years
measure: Rate of colostomy complications
timeFrame: baseline, 6 months, 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital of Sun Yat-Sen University
name: Lei Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan ZX, Ma TH, Wang HM, Zhong QH, Yu XH, Qin QY, Wang JP, Wang L. Colostomy is a simple and effective procedure for severe chronic radiation proctitis. World J Gastroenterol. 2016 Jun 28;22(24):5598-608. doi: 10.3748/wjg.v22.i24.5598.
citation: Ma TH, Yuan ZX, Zhong QH, Wang HM, Qin QY, Chen XX, Wang JP, Wang L. Formalin irrigation for hemorrhagic chronic radiation proctitis. World J Gastroenterol. 2015 Mar 28;21(12):3593-8. doi: 10.3748/wjg.v21.i12.3593.