An interventional study of Hydrocelectomy surgery in Hydrocele of Tunica Vaginalis, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Completed at 1 site in India. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Treatment
There is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. Our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. The potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. There is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.
Study objectives:
Primary:
To compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (CSD).
To compare postoperative pain (testalgia) between the two groups of patients.
Study setting: All patients over 18 years of age attending the outpatient department of General Surgery at AIIMS, Bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery.
Total Sample Size = 60 (30 in each arm)
All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele
Device: Hydrocelectomy surgery
Not placing a drain after hydrocelectomy in primary vaginal hydrocele
Device: Hydrocelectomy surgery
The standardized hydrocelectomy operation i.e. Eversion of the TVT sac
Skin edema
Boggy swelling of scrotal wall
Time frame: Post operative period of 1 month
Hematoma
Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site
Time frame: Post operative period of 1 month
Surgical site infection
Seropurulent discharge from the incision site with systemic signs of infection like fever, tachycardia and local signs like edema, redness and tenderness
Time frame: Post operative period of 1 month
Testalgia
Visual Analog Scale scoring on a 100 mm length scale ( low score with no pain to higher scores with worst imaginable pain) for acute and sub acute testalgia
Time frame: post operative period of 1 month
Plan to share: Yes — Participant information sheet and participant consent form and study protocol.
Supporting information: Study protocol, Icf
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Testicular Hydrocele
All India Institute of Medical Sciences, Bhubaneswar