Impact of Liver Transplantation on Sexual Life and Function

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-60
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after liver transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Married male Patients.

Decompensated Chronic Liver Disease awaiting elective liver transplantation.

Post Liver Transplant patients with stable graft function.

Disqualifiers

Negative consent.

Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).

Acute on Chronic Liver Failure and Acute Liver Failure patients.

Trial population

Chronic Liver Disease patients awaiting elective transplantation and post liver transplant patients.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • No Treatment

    Other intervention

    This is an Observational Study

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Chronic liver Disease1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of sexual function by questionnaire method

Arizona Sexual Experience Scale (ASEX) scores for sexual dysfunction, ASEX scores are 5 point questionnaire with scores given for each question from 1-6. Total scores More than or equal to 19 indicate sexual dysfunction (higher the scores greater the sexual dysfunction).

Time frame
pre transplant, 3,6,12 months
2

Evaluation of erectile dysfunction using questionnaire method

International Index for Erectile Function - 5 (IIEF-5) scores for erectile dysfunction IIEF 5 scores are also a 5 point questionnaire with score ranging 0-6 for each question. Total scores less than 15 indicate mild to moderate erectile dusfunction and scores less than 11 indicate moderate erectile dysfunction (lower the scores higher the erectile dysfunction)

Time frame
pre transplant, 3,6,12 months

Secondary outcomes

1

Correlation between testosterone and Meld Na scores

Testosterone measured in ng/ml. Less than 2.84 ng/ml is considered as hypogonadism

Time frame
pre transplant, 3,6,12 months
2

Sarcopenia implication in recovery of sexual function.

Sarcopenia measured by third lumbar vertebra Skeletal muscle index. Values less than 52 indicates sarcopenia

Time frame
pre transplant, 3,6,12 months

Other outcomes

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