Laparoscopic Extraperitoneal Appendicostomy: A Modified Laparoscopic Appendicostomy Technique for Antegrade Continence Enema in children

In this study, we aimed to introduce a modified extraperitoneal laparoscopic appendicostomy technique for antegrade continence enema (ACE), which might reduce complications like internal herniation that patients face after open or intraperitoneal techniques.

A randomized, single-blinded, case-controlled study with a parallel-group design of 30 patients, enrolled between December 2019 and February 2019, and median follow-up was about six months.

This study was conducted in Shiraz Namazee Hospital. After complete clarification of the study for parents and guardians of patients and completion of their informed consent form, patients underwent one of two types of laparoscopic appendicostomy. The supervisors recorded all the necessary variables without knowing the type of operation.

The study population group consisted of 30 children aged 5-15 years who had functional constipation due to Hirschsprung's disease, and stool incontinence caused by anorectal malformations. The participants were prescribed 3 months of bowel management. All patients with a history of a previous laparotomy, cecal and appendix manipulation, short appendix length, and previous appendectomy were excluded.

The children were randomly assigned into two groups of case and control, in which the first group underwent laparoscopic intra-peritoneal appendicostomy. In contrast, the second group underwent a modified laparoscopic extraperitoneal appendicostomy.

These two groups were compared from the aspect of complete constipation remission or incontinence, ease of catheterization, discharge from appendicostomy, and incidence of stenosis of appendicostomy, need for re-operation and inability of catheterization, number of enemas per day, length of hospital stay, and finally their satisfaction with the operation.

Randomization will be based on permuted block randomization to control the effect of age and sex. Each block will have 6 capacities, ie, we will have 5 blocks of 6. After that, in each block, people randomly enter one of the laparoscopic surgery groups. Randomization within each block will be based on a table of random numbers.

In this single-blind study, all patients and observers were not aware of the type of procedures, but their parents were totally informed. In fact, Only the surgeon aware of grouping all patients' guardians, and parents knew the exact possible procedures and completed the informed consent. On the other hand, observers measured patients 'satisfaction with the procedure, as well as information such as patients' need for reoperation, number of enema per day, and stoma leakage from the appendix tube, and they recorded all data by questionnaires and detailed daily observations.

study design and protocol, statistical process, and the procedure method in detail are planned to share. Patients’ information was de-identified prior to data analysis and confidentiality of patient information was guaranteed and protected by recording only the necessary information regarding this study.

The data will be available since publishing the manuscript which would be probably right after receiving the Clinical trial code ( September 2020)

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Access to the data means analyzing them at the discretion of the applicant and communicating with the responsible author.

Data will be shared just by the corresponding author of the manuscript.

Access to the data will only be possible via email to the responsible author and their response