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.: PACTR201801002931307 Date of Approval: 02/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RCT to compare (PPH) plus (LA) with (PPH) in treatment of grade III and IV hemorroidal
Official scientific title RCT to compare stapled hemorroidopexy (PPH) plus ligation anopexy (LA) with stapled hemorroidepexy (PPH) in treatment of grade III and IV hemorroidal disease
Brief summary describing the background and objectives of the trial The potential benefits of PPH include shorter operative time, less postoperative pain, less urinary retention, and more rapid return to normal activities. Despite these postoperative advantages, long-term results are insufficient, particularly regarding residual skin tags and recurrent prolapse so in the current study we add ligation anopexy to PPH technique to assess its value in improving short and long term results
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,hemorroidal disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/01/2018
Actual trial start date 02/01/2018
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 124
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 a randomisation table by computer software program sealed opaque envelop Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation by computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Stapler haemorrhoidopexy Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.) 62 Active-Treatment of Control Group
Experimental Group Stapler haemorrhoidopexy plus ligation anopexy Stapler haemorrhoidopexy plus ligation anopexy 62
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
grade III and IV hemorrhoids requiring hemorrhoidectomy. ¿ first and second degree hemorrhoids ¿ patients with firm and fibrotic external irreducible haemorrhoids thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment history of inflammatory bowel disease; history of colon, rectal or anal cancer inability to give informed consent age < 18 years pregnant women. 18 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 01/01/2018 alexandria ethical committee
Ethics Committee Address
Street address City Postal code Country
el mery al azzaritta ALexandria 20122 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Symptoms Remission Rate [ Time Frame: 1 month postoperatively ] The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, within one month postoperatively If the symptoms are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'
Secondary Outcome Operative time Time Frame: Intraoperative period The total operative time will be recorded. Measurement unit: minutes
Secondary Outcome Postoperative mobilization time Time Frame: Maximum time frame 24 hours postoperatively ] The postoperative mobilization time of the patient will be recorded. Measurement unit: hours
Secondary Outcome Onset of oral feeding Time Frame: Maximum time frame 24 hours postoperatively
Secondary Outcome Postoperative pain level at 12 hours Time Frame: 12 hours postoperatively
Secondary Outcome Hypotension Time Frame: Maximum time frame 24 hours postoperatively ] Occurrence of postoperative hypotension. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Nausea Time Frame: Maximum time frame 24 hours postoperatively ] Occurrence of postoperative nausea. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Vomiting Time Frame: Maximum time frame 24 hours postoperatively Occurrence of postoperative vomiting. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Headache Time Frame: Maximum time frame 24 hours postoperatively ] Occurrence of postoperative headache. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Urinary retention Time Frame: Maximum time frame 24 hours postoperatively Occurrence of postoperative urinary retention. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Bleeding at the operative site Time Frame: Maximum time frame 24 hours postoperatively Occurrence of postoperative bleeding at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Postoperative discharge time Time Frame: Maximum time frame 48 hours postoperatively Postoperative time that the patient can be safely discharged. Measurement unit: hours.
Secondary Outcome Postoperative pain level at 7 days Time Frame: 7 days postoperatively Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale
Secondary Outcome Oedema at the operative site Time Frame: 7 days postoperatively Occurrence of postoperative oedema at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Hematoma at the operative site Time Frame: 7 days postoperatively Occurrence of postoperative hematoma at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Infection at the operative site Time Frame: 7 days postoperatively Occurrence of postoperative infection at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Stenosis at the operative site Time Frame: 30 days postoperatively ] Occurrence of postoperative stenosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Postoperative return to work time Time Frame: Postoperative period up to 1 month The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days
Secondary Outcome Pruritus Time Frame: 1 year postoperatively Occurrence of postoperative pruritus at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Mucosal prolpase Time Frame: 1 year postoperatively Occurrence of postoperative mucosal prolapse at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Mucosal prolapse Time Frame: 2 year postoperatively
Secondary Outcome Perianal nodules Time Frame: 2 year postoperatively Occurrence of postoperative perianal nodules. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Constipation Time Frame: 2 year postoperatively Occurrence of postoperative constipation. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Tenesmus Time Frame: 2 year postoperatively Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Reoperation Time Frame: 1 year postoperatively Occurrence of reoperation. If the patient is reoperated, then it will be defined as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'
Secondary Outcome Disease recurrence rate Time Frame: 2 years postoperatively Disease recurrence rate If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Secondary Outcome Satisfaction level Time Frame: 2 years postoperatively Satisfaction level measured at a 0-10 scale
Secondary Outcome Difference in the quality of life of the patient Time Frame: Preoperatively, 1 month postoperatively and 1 and 2 years postoperatively ]
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospital el aazaritta Alexandria 21212 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria main university hospital el azzaritta Alexandria 21212 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria main university hospital el azzaritta Alexandria 21212 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Walid Galal Elshazly 1 st ahmed zaki abo shadi Alexandria 21111 Egypt
Mohmed Abd El halim 21 el ekbal st loran Alexandria 22315 Egypt
Ahmed Radwan 12 cleopatre Alexandria 21215 Egypt
Amr samir 15 sharawy st Alexandria 22315 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Galal Elshazly wshazly@gmail.com 0021223493268 1 st ahmed zaki abo shadi
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Professor of colorectal surgery
Role Name Email Phone Street address
Public Enquiries Israa aly israa.aly@alexmed.edu.eg 00212287740750 el mery elazzaritta
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt ethical committee director
Role Name Email Phone Street address
Scientific Enquiries Mohmed halim immerianz@hotmail.com 002110711171 21 el ekbal loran
City Postal code Country Position/Affiliation
Alexandria 22211 Egypt scientic activity organizer
REPORTING
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