Hemorrhoid, Hemorrhoid Bleeding, Hemorrhoid Pain, Hemorrhoid Prolapse, Hemorrhoids, Hemorrhoids Internal
Conditions
Keywords
Endoscopic injection sclerotherapy, Endoscopic Band Ligation, Hemorrhoids, Hemorrhoid, Soft Endoscopy
Brief summary
This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores
Detailed description
Continuous recruitment of symptomatic internal hemorrhoid patients who visited the main center and sub centers was conducted using a stratified block randomization method, with a 1:1 random allocation to the endoscopic injection sclerotherapy group and endoscopic band ligation group for intervention. During the perioperative period, demographic characteristics, intraoperative conditions, postoperative complications and surgery related costs, length of hospital stay were recorded, and HDSS, EQ-5D-5L, EQ-VAS scores were recorded. Changes in scores were recorded during telephone follow-up at 2 weeks, 3 months, and 12 months after surgery, as well as whether the patient's symptoms improved, recurred, and satisfaction was assessed.
Interventions
OTHEREndoscopic injection sclerotherapy
Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.
Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.
Sponsors
Renmin Hospital of Wuhan University
Zhejiang University
The First Affiliated Hospital of Nanchang University
Wuhan Puren Hospital
Yichang Central People's Hospital
Fuyang Second People's Hospital
Hubei Hospital of Traditional Chinese Medicine
Shanxi Provincial Fifth People's Hospital
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Jingzhou First People's Hospital
Chibi People's Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
Central Hospital of Xiaogan
Xiaogan First People's Hospital
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Wuhan University of Science and Technology Affiliated Hanyang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 75, men and women; 2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy; 3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.
Exclusion criteria
1. Age \<18 or age\> 75; 2. External hemorrhoids or mixed hemorrhoids; 3. degree Ⅳ internal hemorrhoids 4. Unsymptomatic internal hemorrhoids 5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection； 6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.; 7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.; 8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal; 9. Women in pregnancy or puerperium; 10. Hardening agent allergy patients, such as polycininol, etc; 11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history; 12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurernce rate | 12 months after surgery | After treatment, the recurrence of internal hemorrhoids symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications and adverse events | Postoperative and follow-up periods | Patients from complications and adverse events following intervention (postoperative bleeding, anal distension, pain, urinary retention and others) |
| early symptom relief rates | 2 weeks and 3 months after surgery | self-rated improvement postoperative 2 weeks and 3 months |
| HDSS | 2 week, 3 month, 12 month after surgery | Hemorrhoid Disease Symptom Score， scale 0-20, high score means better |
| EQ-5D-5L | 2 week, 3 month, 12 month after surgery | the European Quality of Life 5-Dimensions 5-Levels questionnaire, scale -1 \~ 1, high scores means better outcome |
| EQ-VAS | 2 week, 3 month, 12 month after surgery | the European Quality of visual analogue scale, scale 0-100, high value means better |
| Surgical costs | After surgery | Cost of treatment |
| Patient satisfaction survey | 3 months or 12 months after surgery | Patient satisfaction evaluation of the treatment method |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMingkai Chen, M.D
Renmin Hospital of Wuhan University
Outcome results
None listed