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Trial registered on ANZCTR


Registration number
ACTRN12611001044910
Ethics application status
Approved
Date submitted
28/09/2011
Date registered
5/10/2011
Date last updated
5/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of life after transabdominal laparoscopic Hernia repair and free tension open repair
Scientific title
Quality of life after transabdominal laparoscopic Hernia repair (TAPP) Vs Open Lichtenstein repairs for the treatment of inguinal hernia: A controlled Randomized Trial.
Secondary ID [1] 273120 0
Nil
Universal Trial Number (UTN)
U1111-1124-8889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia Surgery 270871 0
Condition category
Condition code
Surgery 279049 279049 0 0
Surgical techniques
Oral and Gastrointestinal 279075 279075 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was done between May 2008 until September 2011, in our university hospital, about 191 cases of unilateral groin hernia, who were fit for general anesthesia and pneumoperitoneum with co2, without complicated hernia, or previous lower abdominal surgery were included. Exclusion criteria also included bilateral and, recurrent hernias. 191 cases were randomly distributed into two groups, using a big container containing 200 balls each ball had a number either one, or, two i.e one hundred ball containing number one, and, another one hundred ball contained number two. After explanation the surgical techniques and the side effects of each technique, and after getting a written consent from the patient to participate in the study, each patient was asked to withdraw one ball with a number, number one means that the patient had undergone laparoscopic transabdominal per-peritoneal mesh repair (TAPP) or group one, and, number two means that the patient belong to the group two or the open Lichtenstein free tension repair. Both procedures were performed under general anesthesia plus a mixtures of 0.5% Bupivacaine, and 1% lidocaine as 1:1 was used to achieve local anesthesia either in inguinal incision or at port site infiltration. Six cases were excluded from laparoscopic group I after surgery, as intra-operative finding of bilateral hernia, and, bilateral repair was done for them, and, they were excluded from the study.
TAPP approach with three port sites was performed in 88 unilateral inguinal hernia patients. With sharp dissection, a posterior peritoneal flap was obtained to expose the internal inguinal ring, the sac was dissected and reduced completely if small or partially excised left in situ if large, continued dissection medially exposing the inferior epigastric vessels, the floor of the inguinal canal or the transverses abdominus arch, Cooper’s ligament, and iliopubic tract.7 by 12 cm polypropylene mesh was used to cover the defect and fixed to the transverses abdominus arch, Cooper’s ligament, and iliopubic tract using stables. The peritoneum was closed over the mesh using stables. periumbilical fascial defect was closed with vicryl number 1.
The open repair was performed in 97 patients according to the technique, described by Lichtenstein et al., 1989
Lichtenstein, I.L., Schulman, A.G., Amid, P.K.: The tension-free hernioplasty.
Am. J. Surg. 159:188, 1989
In both groups skin closure was achieved using subcutaneous monocryl. Follow up of patient early after one month, then every six months or when needed. The definition of chronic pain was depending upon “International Association of the Study of Pain” which defined chronic pain as “pain lasting for 3 months or more,”
International Association for the Study of Pain, Subcommittee on Taxonomy. Classification of chronic pain: descriptions of chronic pain syndromes and definitions of pain terms. Pain 1986;3(Suppl): S1–226.
The Short-Form 36 (SF-36) was used in the first visit to assess quality of life. SF-36 has three levels: (1) items, (2) eight scales that aggregate, and (3) two summary measures (physical and mental health). The eight scales are well known as: physical functioning which expressed by (10 items), social functioning represented by (2 items), role physical limitations was expressed by (4 items), role limitations due to emotional problems as (3 items), mental health represented with (5 items), vitality had (4 items), bodily pain expressed by (2 items), and general health perception represented by (5 items), each item was represented with a score staring by zero for the worst and 100 for the best.
SPSS V 19 was used for data entry. All procedures, patient demographics, and follow-up data were recorded. Results were grouped and statistical significance was determined using the two-sample Wilcoxon rank-sum (Mann-Whitney) test.
The primary end point for the study was the total outcomes of the quality of life, the secondary end point was identifications of the complications of both techniques, recurrent rate, and, technical failure.
Average time of procedure is between 30-60 minutes
Group I or TAPP is the intervention group and Group 2 Lichtenstein free tension repair is the control but active group
Intervention code [1] 269461 0
Treatment: Surgery
Intervention code [2] 269462 0
Lifestyle
Comparator / control treatment
Group I or TAPP is the intervention group and Group 2 Lichtenstein free tension repair is the control but active group
Control group
Active

Outcomes
Primary outcome [1] 279701 0
Quality of Life using SF-36 Quality of Life Questionnaire and scoring for each question beginning at 0-100. data entry and analysis using SPSS V19.
these scores re-code the answers of each question of the SF-36 for example non of the time- a little of the time- some of the time-most of the time- all of the time for the question "Did you feel tired?' in question 9-i , these answers can be coded as 100-75-50-25-0
Timepoint [1] 279701 0
4 Weeks after surgery
Secondary outcome [1] 294258 0
Complication and morbidity as (haemorrahge, seroma, haematoma, ileus, .....etc these data well be collected and SPSS V19 well be used for statistical analysis, presented as numbers and percentage in each group, and compared using the chi square test.

each patient had his own clinical file and follow up sheet in which each complication can be diagnosed clinically by examination assessment or radiological investigation as ultrasound if needed, all data recorded, and re-entered to computer system and SPSS program for statistical analysis
Timepoint [1] 294258 0
within 1-12 Months

Eligibility
Key inclusion criteria
above 18years, diagnosed as inguinal Hernia either direct or indirect, accept to participate 9n the trial, and fit for surgery, had no history of psychological or mental disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent, complicated and bilateral cases, unfit for surgery, refusing trial, or had psychological or mental diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After informed consent, patient had to get a number inside a ball within big container, one means laparoscopic technique to be adopted, 2 means open technique well be adopted
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Number one means laparoscopic technique to be adopted, Number two means open technique well be adopted
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3868 0
Egypt
State/province [1] 3868 0
Dakahlia

Funding & Sponsors
Funding source category [1] 269943 0
Self funded/Unfunded
Name [1] 269943 0
Ashraf E, Abbas
Country [1] 269943 0
Egypt
Primary sponsor type
Individual
Name
Ashraf El-Sayed Abbas
Address
Mansoura University, Mansoura 35516, el-gomhoria st, Egypt
Country
Egypt
Secondary sponsor category [1] 268941 0
None
Name [1] 268941 0
Address [1] 268941 0
Country [1] 268941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271913 0
Local department Ethical comittee
Ethics committee address [1] 271913 0
Mansoura University Hospital Department of Surgery
Mansoura University, Mansoura 35516, el-gomhoria st, Egypt
Ethics committee country [1] 271913 0
Egypt
Date submitted for ethics approval [1] 271913 0
Approval date [1] 271913 0
01/04/2008
Ethics approval number [1] 271913 0

Summary
Brief summary
The study designed to test the effect of surgical procedures used on the health and quality of life of the participants, beside their possible side effects or complication, in two different group of patients who were selected and distributed random-ally for the two techniques of surgeries ( open or laparoscopic)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33207 0
Address 33207 0
Country 33207 0
Phone 33207 0
Fax 33207 0
Email 33207 0
Contact person for public queries
Name 16454 0
Ashraf El-Sayed Abbas
Address 16454 0
El-Gomhoria st , Mansoura university Hospital, Zip Code 35516, A.R.E
Country 16454 0
Egypt
Phone 16454 0
+20184777248
Fax 16454 0
+20502267016
Email 16454 0
[email protected]
Contact person for scientific queries
Name 7382 0
Ashraf El-Sayed Abbas
Address 7382 0
El-Gomhoria st , Mansoura university Hospital, Zip Code 35516, A.R.E
Country 7382 0
Egypt
Phone 7382 0
+20184777248
Fax 7382 0
+20502267016
Email 7382 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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