Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001587102 Date of Approval: 14/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Colectomy and immediate anastomosis versus on-table colonic lavage for the management of acutely obstructed left colon
Official scientific title Colectomy and immediate anastomosis versus on-table colonic lavage for the management of acutely obstructed left colon
Brief summary describing the background and objectives of the trial Acute left colonic obstruction is a common surgical emergency that occurs with subtle clinical manifestations preceding the full-blown picture of absolute constipation and massive abdominal distension. Colonic obstruction is mostly caused by carcinoma of the left colon; up to 20% of patients with colonic cancer present with symptoms of acute obstruction, but diverticulitis of the sigmoid, colonic volvulus and endometriosis may also cause acute obstruction. Several options exist for the emergency management of obstructed left colon lesions. Hartmann's procedure is performed in case of high risk of anastomotic dehiscence but up to 60% of stomas are never reversed, the expense and morbidity of the takedown procedure are significant and the patients have to make physical and psychological adjustments to live with a stoma. Subtotal and total colectomy should be attempted when caecal perforation is eminent or in case of synchronous colonic neoplasm. However, reduced capacity rectal stump leads to frequent passage of stool, affecting the quality of life. When skills and equipments are available, colonic stents tend to be an acceptable option in the palliative setting but a definitive solution can't be achieved if used alone. Based on the successful experiences of urgent colon surgery for penetrating trauma and in elective colonic anastomosis without previous preparation, studies have shown that primary colonic anastomosis is safe even though mechanical bowel preparation was not performed before surgery. Resection with immediate anastomosis has recently found its place in managing emergency presentations of diverticular disease, sigmoid volvulus and undoubtedly, obstructed malignant colonic strictures. Simultaneous reconstruction after segmental resection can be performed by manual decompression either with or without on table colonic lavage. The idea of intra-operative lavage is to clean the bowel from any solid fecal matter thereby decreasing chances of contamination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied ,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 14/04/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 14/05/2016
Actual Last follow-up date 14/05/2016
Anticipated target sample size (number of participants) 212
Actual target sample size (number of participants) 212
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
surgical outecomes of managment of obstructed left colon faculty of medicine, alexandria university, egypt
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using closed envelope technique sealed opaque envelopes technique Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group immediate anastomosis Simultaneous reconstruction after segmental resection of left colon Simultaneous reconstruction after segmental resection Simultaneous reconstruction after segmental resection 108 Active-Treatment of Control Group
Experimental Group on-table colonic lavage on-table colonic lavage after resection followed by anastomosis on-table colonic lavage after resection followed by anastomosis on-table colonic lavage after resection followed by anastomosis 104
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Causes were either, malignant strictures of the left side of the colon at or below the splenic flexure. - or benign disorders including volvulus of the sigmoid colon and colonic stricture secondary to a complicated diverticular disease. - Patients with irresectable or perforated tumors. - hypoalbuminia (below 2.5g/dl). - anemia (below 8 mg%). - malignant ascitis. - ASA (American Society of Anaesthesiologists) score more than III due to severe co-morbidities. - or those with poor general risk factors affecting the integrity of anastomosis as well as tight rectal cancers, 44 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/02/2013 faculty of medicine, alexandria university, egypt
Ethics Committee Address
Street address City Postal code Country
shamblion st, elazarita, alexandria, egypt alexandria 21532 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the duration of the operation the duration of the operation
Secondary Outcome the amount of blood loss, the hospital stay, operative and postoperative complications) operative and postoperative complications
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, alexandria university, egypt shamblion st, elazarita, alexandria alexandria 21532 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, alexandria university, egypt shamblion st, elazarita, alexandria alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Mohamed Ibrahim kassem, faculty of medicine, alexandria university shamblion st, elazarita, alexandria alexandria 55555 Egypt Funding Agency
Primary Sponsor faculty of medicine, alexandria university, egypt shamblion st, elazarita, alexandria alexandria 21532 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hany Mostafa Elhaddad shamblion st, elazarita, alexandria alexandria 21532 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed kassem dr_m_kassem@yahoo.com +201001224750 17 shaarawy st, louran, alexandria
City Postal code Country Position/Affiliation
alexandria 55555 Egypt assistant professor of surgery , faculty of medicine, alexandria university, egypt
Role Name Email Phone Street address
Public Enquiries hany elhaddad drhanyelhaddad@yahoo.com 00201001989132 sidigaber, alexandria
City Postal code Country Position/Affiliation
alexandria 4563 Egypt lecturer of surgery, faculty of medicine, alexandria university
Role Name Email Phone Street address
Scientific Enquiries mohamed kassem dr_m_kassem@yahoo.com +201001224750 17 shaarawy st, louran, alexandria
City Postal code Country Position/Affiliation
alexandria 55555 Egypt assistant professor of surgery , faculty of medicine, alexandria university, egypt
REPORTING
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