Commentary on "Postoperative outcomes of sigmoid colon vaginoplasty for vaginal agenesis: A randomized controlled trial".

Dear Editor,

We have read the interesting article “Postoperative outcomes of sigmoid colon vaginoplasty for vaginal agenesis: A randomized controlled trial” published in Annals of Medicine and Surgery on May 17, 2022 [1].

The study is claimed to be a randomized controlled trial in the title and methodology but on the contrary, all 39 patients registered in the study underwent sigmoid colon vaginoplasty and no control group was identified. A randomized controlled trial essentially involves an experimental group and a control group receiving the conventional treatment. This is not to mention that there is no randomization of the subjects. The article again mentions that “the methods are stated in line with the CONSORT statement for randomized controlled trials. This confirms that the authors are well aware of the type of study in which they want to label their article but did not comply with the CONSORT statement [2].

The exclusion criteria include the previously operated cases however, during the discussion, a complication associated with a previous McIndoe surgery has been mentioned. The details of associated problems were not mentioned and the type of MRKH syndrome is not specified. The procedure details mention the phrase “colon was immobilized”, instead of “colon was mobilized”.

Furthermore, the study is about the post-operative outcomes but the results are not detailed and only the mean values are reported. The mean follow-up duration is 7.1 weeks which is too short to assess the outcomes of vaginoplasty, especially the sexual satisfaction scores. Only 10 out of the 39 patients (30%) were sexually active post-operatively hence the scales of female sexual function index (FSFI) and sexual satisfaction scale were not even applicable to all the patients. The mean value of the FSFI score is calculated to be 32 ± 3.9 but the methodology for calculating the score is not mentioned anywhere [3,4].

The article is very much misleading to the readers right from the title and the design of the study. The publication of an article in a peer-reviewed indexed esteemed journal is not justified in its present form and therefore we suggest that the study should be modified immediately.

Ethical approval

Not required.

Sources of funding

None.

Author contribution

The contribution of the authors as mentioned below with their responsibility in the research.

Devprabha Bhagat-writing the manuscript, data collection

Rahul Saxena - conceptualizing, analyzing, and writing the manuscript

Arvind Sinha-revision of the manuscript and providing intellectual content for manuscript

Registration of research studies

Name of the registry: NA

Unique Identifying number or registration ID: NA

Hyperlink to your specific registration (must be publicly accessible and will be checked):

Guarantor

Dr. Rahul Saxena, Associate Professor, Department of Pediatric Surgery, All India Institute of Medical Sciences, Jodhpur, India- 342008, E-mail – drrahulsaxena@gmail.com, Ph-+919587326200.

Previous communication

None.

Declaration of competing interest

None.